Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children

NCT ID: NCT07012512

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-30

Brief Summary

The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.

Detailed Description

To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).

Interventions

Cycloplegia Induction:

Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).

Reversal Agents (administered at 30 minutes post-cyclopentolate):

Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.

Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.

Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.

Conditions

Pupillary Constriction; Accomodation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Pilocarpine group

Children will receive pilocarpine drops in one eye and placebo in the other

Group Type: EXPERIMENTAL

Pilocarpine 0.1%

Intervention Type: DRUG

Use of pilocarpine 0.1% to reverse cycloplegia

Phentolamine group

Children will receive phentolamine eye drop in one eye and placebo in the other

Group Type: ACTIVE_COMPARATOR

Use of phentolamine eye drops to reverse cycloplegia

Intervention Type: DRUG

Use of phentolamine 0.75% eye drops to reverse cycloplegia

Combined

Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other

Group Type: EXPERIMENTAL

Combination of pilocarpine 0.1% and phentolamine 0.75%

Intervention Type: DRUG

Combination of pilocarpine 0.1% and phentolamine 0.75%

Interventions

Use of phentolamine eye drops to reverse cycloplegia

Use of phentolamine 0.75% eye drops to reverse cycloplegia

Intervention Type: DRUG

Pilocarpine 0.1%

Use of pilocarpine 0.1% to reverse cycloplegia

Intervention Type: DRUG

Combination of pilocarpine 0.1% and phentolamine 0.75%

Combination of pilocarpine 0.1% and phentolamine 0.75%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children between 5 and 12 years undergoing cycloplegia

Exclusion Criteria

• Patient refusal

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ahmed AlNagdy

Role: CONTACT

imanatta@mans.edu.eg

+201096710982

Other Identifiers

Mansoura university Ophthalmic

Identifier Type: -

Identifier Source: org_study_id